K241591
- 510(k) number
- K241591
- Device name
- Blue Eye
- Applicant
- The Standard Co., Ltd. KR
- Product code
- PLL — Submucosal Injection Agent
- Decision date
- 2024-07-03
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241591.pdf
Official FDA record: K241591
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.